1. International Aspects of Plant Variety Protection 2. India’s Position: PVPFR Act

10BT81 Unit 8

1 INTRODUCTION

. Importance of modern biotechnology in plant breeding

. IPR protection is independent from commercialization procedures

. Issues resulting from the differences between the scope and the exceptions of the patent and breeder’s rights systems

2 Exclusion from patentability

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation

If necessary to protect public order or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by domestic law. Art.27 (2)

3 Exclusion from patentability . Members may also exclude from patentability: a) Diagnostic, therapeutic and surgical methods for the treatment of humans or animals; b) Plants or animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system by any combination thereof {Art.27(3) (b)} 4 Article 27 (3)(b) of TRIPS

“…members shall provide for the protection of plant varieties either by patents or an effective sui generis system or by any combination thereof” . For developing using a national yardstick, an effective system would stimulate research and development of plant varieties without compromising national welfare goals.

. It would prioritize goals like:

 Food security.

 Biodiversity protection

 Sustainable development of indigenous communities, etc. International Aspects: UPOV

PLANT VARIETY PROTECTION CRITERIA : . Distinctiveness . Uniformity . Stability . Novelty . Appropriate Denomination (for sale)

7 Novelty Requirements

 Commercial Novelty: Art. 6 of UPOV  The variety shall be deemed to be new if, at the date of filing of the application for a breeder's right, propagating or harvested material of the variety has not been sold or otherwise disposed of to others, by or with the consent of the breeder, for purposes of exploitation of the variety

•Excludes cultivation, reference collection, publication etc,. •Allows the breeder to claim protection over genetic varieties that have been cultivated for centuries but never sold. Distinctiveness Requirement

Article 7 of UPOV: . “The variety shall be deemed to be distinct if it is clearly distinguishable from any other variety whose existence is a matter of common knowledge at the time of filing the application.”

Application materials that are a matter of common knowledge can pass the test of distinctiveness if it can be distinguished from another material that is a matter of common knowledge. . Art 14: . A variety is “a matter of common knowledge,” under article 14 of UPOV, if it has been subject “of an application for the granting of a breeder's right” or has been entered in the official register of varieties, in any country” UPOV 1961, 1978, 1991

 1961 European Convention: Requirements: – New – Distinct – Stable – Uniform – Biological deposit

 1978 Act: Scope of protection • Authorization of the breeder is required for: – Production for the purpose of commercial marketing; – Offering for sale; and – Marketing of the reproductive or vegetative material, as such, of the variety • Protection may be extended to the harvested product • Exception to Breeder’s Right (for creating new varieties)11  1991 UPOV • Strengthen breeders’ rights • Weakened exemptions to breeders’ rights, particularly farmer’s exemption • Removed prohibition on dual protection

 U.S. PVPA (amended 1994) patterned after UPOV 1991

 Plant variety certificates

12 UPOV 1991 Act Scope of protection

1978 Act (Article 5(1)) 1991 Act (Article 14(i))

Production for the purposes of Production or reproduction (multiplication) commercial marketing Conditioning for the purpose of propagation

Offering for sale Offering for sale

Marketing Selling or other marketing activities

Exporting

Importing

Stocking for any of the above purposes 13 The 1991 Act . The protection is extended to the harvested material obtained through the unauthorized use of propagating material . Each contracting party may extend the protection to the products made directly from the harvested material . Unless, in both cases, the breeder has had a reasonable opportunity to exercise his right in relation to the propagating material . The authorization of the breeder is required for the exploitation of essential derived varieties (EDV) of a protected variety.

14 The 1991 Act Exceptions to the Breeder’s Right (1) Compulsory exceptions: . Acts done privately and for non-commercial purposes . Acts done for experimental purposes . Acts done for the purpose of breeding other varieties and, except if the new variety is essentially derived, exploitation of that new variety

15 The 1991 Act

Exceptions to the Breeder’s Right Optional exception:

. Each contracting party may, within reasonable limits and subject to the safeguarding of the legitimate interest of the breeder, restrict the breeder’s right in order to permit farmers to use, on their own farm, farm saved seeds

16 Plant Breeder’s Rights

Conclusions . The 1978 UPOV Convention is a weak protection system, probably non “effective” in the meaning of the TRIPs Agreement

. The 1991 UPOV Convention is an effective protection system, provided that the clause on farm saved seed is implemented properly by the contracting parties

17 Utility Patents for Plant Varieties

. The first utility patent for a plant in the USA was granted in 1986 for a high-tryptophan corn . Since 1986 hundreds of utility patents have been granted for plant varieties in the USA . It is also possible to grant patents for plant varieties in other countries, such as Japan and Australia, but that possibility is not used frequently by seed companies

18 Utility Patents for Plant Varieties

Perceived avantages of Utility Patents by some companies . Balancing the protection of plant varieties with the protection of biotech inventions . Ban of farm saved seed in general . Elimination of the breeder’s exception

19 TRIPS Agreement UPOV (Article 28) (1991 Act – Article 14)

“1. A patent shall confer on its owner the “(1) [Acts in respect of the propagating following exclusive rights: material] (a) where the subject matter of a (a) Subject to Articles 15 and 16, the patent is a product, to prevent third following acts in respect of the propagating parties not having the owner’s material of the protected variety shall consent from the acts of: require the authorization of the breeder:

making, (i) production or reproduction using, (multiplication), (ii) conditioning for the purpose of propagation, offering for sale, (iii) offering for sale, selling, or (iv)selling or other marketing,

Importing (v) exporting, (vi) importing,

for these purposes that product;” (vii) stocking for any of the purposes20 mentioned in (i) to (vi), above.” Exceptions to the rights conferred by a patent . Article 30 of the TRIPS Agreement states that: “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”

. Open multilateral treaties in the field of patents do not provide for the extent to which those limited exceptions may be permitted

. Necessary to refer to national or regional patent legislation and to relevant jurisprudence 21 The ability to exercise the breeder’s exemption in the case of varieties containing patented inventions

. purpose of the patent is to protect the developer of the genetic element

. purpose of the plant breeder’s right is to protect the developer of the unique combination of plant germplasm forming the variety

. exercise of breeder’s exemption constrained due to lack of similar provision in patent system 22 European Union . European Patents Convention, 1973: single application is enough. . EU Directive on the Legal Protection of Biotechnological Inventions 1988/1995 . European Council for Regulation of Community wide system of Plant Variety Rights, 1994. . EPC prohibits patents for plant varieties. . Microbiological processes are patentable. . 1994 law provides rights for plant varieties and EDV. . Farmers’ privilege only through national laws.

23 PPV& FR Act, 2001

24 Protection of Plant Varieties & Farmers’ Rights Act, 2001

. Passed to provide an alternative protection to plant varieties as provided in Art. 27(3) of TRIPS.

. Objectives: 1. Establishing an effective system of protection of plant varieties. 2. Protection of farmers’ rights. 3. Protection of plant breeders’ rights.

. Functions of the Authority: I. Promoting and encouraging development of new varieties of plants. II. Protecting the rights of farmers and breeders. 25 Mechanism for Achievement . Registration of extant new varieties. . Developing characterisation and documentation of registered varieties. . Documentation, indexing and cataloguing of farmers’ varieties. . Compulsory cataloguing for all varieties of plants. . Ensuring that registered seeds are available to farmers. . Collection of statistics of plant varieties.

. Ensuring maintenance of register. 26 Registerable Varieties: Sec 15 . A new variety: novelty, distinctiveness, uniformity & stability. . An extant variety: distinctiveness, uniformity & stability. . Essentially Derived Variety. . Definition of Extant Variety: Sec 2(j) i. Notified u/S 5 of Seeds Act 1966; ii. Farmers’ variety; iii. Variety of common knowledge; and iv. Variety in public domain.

27 Who can apply?

. Breeder of the variety. . Successor of the breeder. . Assignee of the breeder. . Farmer of group of farmers or community of farmers as breeder. . Person authrised by any of the above. . University or publicly funded agricultural institution as breeder.

28 What the form shall contain? . A single and distinct denomination to a variety. . Affidavit that it contains no terminator technology. . Complete passport data of parental line, geographical location, contribution of farmer, community, etc. . Brief description of the variety. . Declaration as to legal acquisition of genetic material or parental material.

29 Defective denomination of a new variety 1. Not capable of identifying such variety 2. Consists solely of figures. 3. Misleading and confusing as to character, etc. 4. Not different from any registered denomination. 5. Deceives public or causes confusion regarding identity of such variety. 6. Hurts religious sentiments. 7. Prohibited u/ Emblems & Names Act 1950.

30 Duration of registration

Type Total Renewal Period Period Trees & Vines 18 years 9 years

Extant Varieties 15 years 6 years

Others 15 years 6 years

31 Benefit Sharing

. Authority to establish contents of certificate & invite claims of benefit sharing. . Claims can be by person, firm, government or NGO. . Enquiry & hearing from both sides. . Order explicitly indicating amount of benefit sharing. . Deposits in the National Gene Fund. Rights conferred on breeders

1.Exclusive right to produce, sell, market, distribute, import or export the variety. 2.To authorise any person to produce, sell, market, or otherwise deal with the variety.

33 Exclusion of Certain Varieties . To protect public order or morality or human, animal or plant life and health and environment. . Central Government to notify the genera or species for registration (other than Extant & Farmers’ Varieties). . Deletion of any genera or species from notification in the public interest.

34 Revocation 1. Grant based on incorrect information. 2. Granted to ineligible persons. 3. Breeder’s failure to provide required information, documents or material. 4. Breeder’s failure to provide an alternative denomination of the variety when required. 5. Breeder’s failure to provide seeds or propagating material to compulsory licensee. 6. Breeder's failure to comply with provisions of the Act, rules or regulations. 7. Grant is not in the public interest. 35 Farmers’ Rights 1. Farmers’ to register a new variety. 2. Recognition & reward for conservation of genetic resources. 3. Entitlement to save, use, sow, resow, exchange, share or sell his produce including seed of protected variety (not if branded). 4. Right to receive compensation if propagating material supplied fails to provide required performance. 5. Innocent infringement is protected. 6. Exemption from fee. 7. Share in the Gene Fund. 8. Consent of farmer in the case of EDV from his Farmer’s Variety. 36 Rights of the Communities

. Claim filing by any person, group, government organisation or NGO on behalf of community for contribution. . Compensation after due hearing.

37 PROTECTION OF PLANT VARIETIES AND FARMERS’ RIGHTS AUTHORITY, INDIA

To establish an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants, it has been considered necessary to recognize and protect the rights of the farmers in respect of their contribution made at any time in conserving, improving and making available plant genetic resources for the development of the new plant varieties

38 . To accelerate agricultural development, it is necessary to protect plants breeders' rights to stimulate investment for research and development for the development of new plant varieties. . Such protection is likely to facilitate the growth of the seed industry which will ensure the availability of high quality seeds and planting material to the farmers. . To give effect to the aforesaid objectives the Protection of Plant Varieties and Farmers' Rights Act, 2001 has been enacted in India. . For the purposes of this Act, Protection of Plant Varieties and Farmers' Rights Authority has been established and is located at New Delhi 39 Overlapping International Agreements

1992 Convention on Biological Diversity; EIF Dec 93

2001 FAO International UPOV 91; Treaty; EIF Apr 98 not IF

1994 WTO TRIPS; EIF Jan 95

40 Geographical Indications

10BT81 Unit 8

41 GIs – the concept . GIs are essentially the DNA of Nature impregnated into the Mother Earth – difficult to clone and beyond scientific calculation. . GIs are about culture, geography, traditions, heritage and traditional practices of people and countries.

42 Geographical Indications

Any noun or adjective (need not necessarily be a geographical name) that designates geographical location and would tend to be regarded by buyers as descriptive of the geographical location of origin of goods.

43 . BenefitsInstrument of Rural ofDevelopment GIs - promotion of products having certain characteristics could be of considerable benefit to the rural economy, in particular to less-favored or remote areas, by improving the incomes of farmers and by retaining the rural population in these areas e.g. Italian Tuscan Olive Oil sold at premium ever since its registration in 1998.

. Differentiation of products can lead to:

 Increase in prices of the protected products

 Allows genuine producers to capture the rents, entry barriers for “fakes”

. More Antiguan Coffee and Darjeeling Tea sold than produced - shows large market for genuine products.

44 Indian GI Act Framework

. GIs can be granted to an individual, a family, a partnership, a corporation, a voluntary association etc or any organization or authority established by or under any law for the time being in force representing the interest of the producers of the concerned goods. . GIs protect and reward traditions while allowing for products to evolve over time . GIs can be protected over long periods as long as the collective tradition is maintained –

 Indian Act protects GIs for an initial period of 10 years, which can be renewed after the expiry of the initial period of protection for another 10 years

 GIs would cease to be on the register if not renewed six months after the expiration of the last registration

45 India’s famous GIs

. Banarasi silks . Nilgiri tea . Paschmina shawls . Coorg coffee . Kashmir carpets . sandal products . Basmati rice . Mysore silk . Darjeeling tea . Malabar pepper . Assam tea . Kancheepuram silks . Bengal Cotton . Lonawala chikis (food stuff) . Alphonso Mangoes . Nilgiri tea . Pochampalli silk . Coir products from Kerala . Chanderi silk . Cardamom from Kerala . Hyderabad pearls . Aranmula mirrors . Kerala Nendran bananas . Nagpur oranges . Jaipur silver jewellery . Phulkari embroidery work

46 Geographical Indication Product State Date of Registration Darjeeling Tea Tea West Bengal 29.10.04 Pochampally Ikat Textile 31.12.04 Chanderi saree Textile Guna, 28.01.05 Madhya Pradesh Kotpad Handloom fabric Textile Koraput, Orissa 02.06.05 Kota Doria Textiles Kota, Rajasthan 05.07.05 Kancheepuram silk Textiles 02.06.05 Bhavani Jamakkalam Textile, carpets Erode,Tamil Nadu 05.07.05 Mysore Agarbathi Incense sticks Mysore, 02.06.05 Aranmula Kannadi Metal Mirror Kerala 19.09.05 Salem Fabric Textiles Tamil Nadu 19.09.05 Solapur Chaddar Textiles Maharashtra 19.09.05 Solapur Terry Towel Textiles Maharashtra 19.09.05 Mysore Silk Textiles Karnataka 28.11.05 Kullu Shawl Textiles Himachal Pradesh 12.12.05 Madurai Sungudi Textiles Tamil Nadu 12.12.05 Kangra Tea Tea Himachal Pradesh 12.12.05 47 Geographical Indication Product State Date of Registration Coorg Orange Horticulture Karnataka 30.01.2006 Product Mysore Betel Leaf Horticulture Karnataka 30.01.2006 Product Nanjanagud Banana Horticulture Karnataka 30.01.2006 Product Mysore Oil Essential Oil Karnataka 30.01.2006

Mysore Sandal Soap Soap Karnataka 30.01.2006

Bidriware Handicrafts Karnataka 30.01.2006

Channapatna Toys and Dolls Handicrafts Karnataka 30.01.2006

Coimbatore Wet Grinder Wet Grinder Tamil Nadu 30.01.2006

Mysore Rosewood Inlay Handicrafts Karnataka 30.01.2006

Kasuti Embroidery Embroidery Karnataka 30.01.2006 (Textiles) Mysore Traditional Paintings Paintings Karnataka 30.01.2006 48 Case of Basmati Rice

. Bas – Aroma, Basmati – Aromatic Rice . Production area – belt on Northern India and adjacent part of Pakistan . Unique Characteristics – long grain (increases substantially on cooking), distinctive aroma and taste. . Case for joint registration – India and Pakistan.

49 . In India the Geographical Indications of Goods (Registration and Protection) Act, 1999 came in force with effect from September 2003.

. The salient features of the Act are defines Geographical Indication, provides a mechanism for registration of GIs, establishes a GI Registry, elaborates the concept of authorised user and registered proprietor, higher level of protection for notified goods and remedies for infringements.